Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 4:08 AM
Study NCT ID:
NCT07482358
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TCI-Massage Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D012917', 'term': 'Social Adjustment'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012919', 'term': 'Social Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-16', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chronic Pain', 'timeFrame': '0, 3, and 6 months', 'description': 'The Graded Chronic Pain Scale-Revised (GCPS-R) is a validated, self-report measure that classifies chronic pain severity into four grades based on pain intensity and interference with daily activities: Grade I (low disability, low intensity), Grade II (low disability, high intensity), Grade III (high disability, moderately limiting), and Grade IV (high disability, severely limiting).35 The GCPS allows for the calculation of the Pain, Enjoyment of Life and General Activity (PEG) Scale, which assesses pain intensity and its impact on general activity and enjoyment of life. The PEG consists of three items rated on a 0-10 scale; the total score is the average of these ratings, with higher scores indicating greater pain severity and interference.'}], 'secondaryOutcomes': [{'measure': 'PTSD', 'timeFrame': '0, 3, and 6 months', 'description': 'The Posttraumatic Diagnostic Scale (PDS-5) is a validated 20-item self-report measure that assesses PTSD symptoms in adults, based on DSM-5 diagnostic criteria.34 For this study, the original 5-point Likert response format was adapted to a simplified 4-point scale to facilitate administration with the clinic population. Total scores are calculated by summing responses across all 20 items, with higher scores indicating greater symptom severity. Due to the clinical adaptation and for comparability with prior literature, we calculated an approximate original metric total by rescaling item scores (multiplying by 4/3) to recover the 0 to 4 item range (scale totaling 0-80).'}, {'measure': 'Anxiety', 'timeFrame': '0, 3, and 6 months', 'description': 'The Hopkins Symptom Checklist-25 (HSCL-25) is a validated, self-report 25-item inventory that assesses anxiety and depression symptoms.33 It includes 10-item anxiety subscale and a 15-item depression subscale, using a 4-point Likert scale, with higher scores suggesting greater symptom severity. Mean scores are calculated for each subscale, with established cutoffs of ≥1.75 commonly used to indicate clinically significant symptoms.'}, {'measure': 'Depression', 'timeFrame': '0, 3, and 6 months', 'description': 'The Hopkins Symptom Checklist-25 (HSCL-25) is a validated, self-report 25-item inventory that assesses anxiety and depression symptoms.33 It includes 10-item anxiety subscale and a 15-item depression subscale, using a 4-point Likert scale, with higher scores suggesting greater symptom severity. Mean scores are calculated for each subscale, with established cutoffs of ≥1.75 commonly used to indicate clinically significant symptoms.'}, {'measure': 'Introception', 'timeFrame': '0, 3, and 6 months', 'description': 'Interoceptive awareness will be assessed using the Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2). The MAIA-2 is a 37-item self report measure designed to assess multiple dimensions of bodily awareness. The measure includes eight domains: noticing body sensations, the tendency not to distract from discomfort, the tendency not to worry about discomfort, attention regulation, emotional awareness of the connection between body sensations and emotions, self regulation through attention to bodily sensations, body listening for insight, and trust in the body as safe and reliable. Items are rated on a six point Likert scale from 0 to 5. Scores are calculated as the average of items within each domain, with higher scores indicating greater interoceptive awareness.'}, {'measure': 'Blood Pressure', 'timeFrame': '0, 3, and 6 months', 'description': 'Seated blood pressure was measured using an automated oscillometric monitor (OMRON Upper Arm Monitor). Participants were seated in a resting position for 10 to 15 minutes before the first reading. An appropriately sized cuff was placed on the bare upper arm at heart level, and the arm was supported on a solid surface with legs uncrossed and feet flat on the ground throughout measurement. Participants refrained from talking during measurements. Three readings were obtained at sixty-second intervals to allow physiologic stabilization, and if a reading failed, it was repeated after three minutes.'}, {'measure': 'Heartrate Variability', 'timeFrame': '0, 3, and 6 months', 'description': 'Heart rate variability (HRV) was measured using the Equivital wireless physiological monitoring system. HRV reflects the variation in time intervals between consecutive heartbeats and is a noninvasive indicator of autonomic nervous system function. Data were collected while participants were seated quietly for a minimum of 10 minutes. The measure administrator received training and followed a standardized protocol for data collection.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PTSD', 'Chronic Pain', 'Depression', 'Anxiety Disorders', 'Social Functioning']}, 'descriptionModule': {'briefSummary': 'The goal of this hybrid implementation-effectiveness study is to learn about the effectiveness and appropriateness of "Trauma-Informed and Culturally-Responsive Integrated Massage Therapy" (TCI-Massage) for torture and war trauma survivors.\n\nThe study aims are: • Examine the uptake of TCI-Massage within CVT by assessing key implementation science outcomes of acceptability and appropriateness among refugees and asylum seekers from diverse cultural backgrounds. • Examine the integration of massage therapy into the current psychosocial care model used at CVT. • Examine the effectiveness of TCI-Massage for torture and war trauma survivors to reduce distress (mental health symptoms, chronic pain, and HRV) and improve coping (interoceptive awareness and social functioning).\n\nTreatment group participants will participate in psychosocial care services + TCI-Massage, which the control group will only participate in psychosocial care services', 'detailedDescription': 'The proposed project is a hybrid implementation effectiveness study. To examine effectiveness, the investigators will use a two group wait list randomized trial with repeated measures.\n\nAim 1: Implementation Science Aim. Examine the uptake of TCI Massage within CVT by assessing key implementation science outcomes of acceptability and appropriateness among refugees and asylum seekers from diverse cultural backgrounds.\n\nAim 2: Implementation Science Aim. Examine the integration of massage therapy into the current psychosocial care model used at CVT. This aim involves examination of system level information including scheduling, session duration, care consultation, implementation costs, and in depth interviews with key clinical staff.\n\nAim 3: Health Outcome Aim. Examine the effectiveness of TCI Massage for torture and war trauma survivors to reduce distress (mental health symptoms, chronic pain, and HRV) and improve coping (interoceptive awareness and social functioning).\n\nResearch Strategy and Design.\n\nDesign. This study is a hybrid implementation effectiveness study. The implementation study involves surveys and focus groups with clinical staff and examination of system level outcomes such as cost, administrative burden, and scheduling. The effectiveness study involves a two group randomized controlled trial using a wait list control and repeated measures. Fifty patients will be recruited for participation and randomly assigned to a treatment group receiving TCI Massage plus usual care or to a control group receiving usual care only and placement on a wait list for TCI Massage. The wait list control group will receive TCI Massage after a three month wait period. Assessments will be administered at baseline, three months, and six months.\n\nInclusion criteria:\n\n1. Refugee or asylum seeker who has experienced torture or war related trauma\n2. Currently receiving care at one of the CVT clinics offering the study\n3. Moderate to high levels of pain assessed through the Graded Chronic Pain Scale\n\ne) Age between 18 and 70 years\n\nExclusion criteria:\n\n1. Currently receiving massage therapy services\n2. Presence of high risk medical condition(s) requiring referral to more intensive services or hospitalization such as inpatient psychiatric care\n\nUsual Care Condition. All patients will engage in a multimodal psychosocial care approach including psychotherapy, social work, and medical services. Clients receive weekly or biweekly psychotherapy and social work services. Clients also have access to primary care services through the Healing Hearts program and to nursing and physician services.\n\nIntervention Condition. Trauma informed and culturally responsive integrated model of massage therapy (TCI Massage).\n\nMassage therapy over clothes will be provided for one hour once per week for eight weeks. The protocol for TCI Massage includes several defining elements described below.\n\nIntake. The initial fifteen minutes of each session involve an intake to assess participant well being, symptoms, and trauma related information that may inform session orientation. Torture and war survivors often demonstrate heightened sensitivity to physical touch and extensive histories of physical and interpersonal trauma and pain. Additional time supports the establishment of safety and trust, agreement on boundaries regarding acceptable types of touch and intensity, and collaboration in cultural adaptation.\n\nMassage. A forty five minute massage therapy session will be provided based on an established massage protocol used in previous massage therapy research. Participants will also receive weekly training in self massage from the massage therapist to extend and enhance the benefits of massage therapy interventions.\n\nData Collection Procedures and Measures or Methods presented below specific to aim.\n\nImplementation Science Aim 1.\n\nData Collection Procedures. A trained facilitator will conduct in depth interviews with study participants at the close of treatment. Interviews will address acceptability and appropriateness of the intervention provided within the CVT clinical context. A trained facilitator will also conduct quarterly focus groups with CVT clinical staff including massage therapists, psychotherapists, social workers, and medical providers. Focus groups will address perceived acceptability and appropriateness.\n\nImplementation Science Aim 2.\n\nData Collection Procedures. Monthly staff surveys addressing feasibility and fidelity will be administered. At the conclusion of the study, analysis of administrative data will assess the level of penetration of the intervention within the organization. After completion of the intervention, a financial review will assess implementation costs associated with the intervention rather than study costs.\n\nHealth Outcome Aim 3.\n\nData Collection Procedures. A research coordinator will administer all assessments. Assessments will include standardized measures of mental health symptoms, pain, and coping including interoceptive awareness and social functioning at baseline, three months, and six months. Objective physiological measures of cardiovascular health will also be collected at each time point. Trained professional interpreters will provide language support for measure administration.\n\nMeasures. The following measures will be administered. Pain will be assessed using the Graded Chronic Pain Scale designed to evaluate pain severity and the extent to which pain interferes with daily life.\n\nMental health conditions assessed will include Major Depressive Disorder, Generalized Anxiety, and Posttraumatic Stress Disorder (PTSD). Generalized anxiety will be measured using the Hopkins Symptom Checklist 25 (HSCL 25), composed of twenty five items with ten items assessing anxiety symptoms and fifteen items assessing depression symptoms. Each item includes four response options: Not at all, A little, Quite a bit, and Extremely. PTSD symptoms will be assessed using the Posttraumatic Diagnostic Scale 5, a self report measure of PTSD aligned with the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders.\n\nSocial functioning will be measured using the Center for Victims of Torture Social Circumstances and Functioning Inventory (CVT SCFI). The inventory was developed by the Center for Victims of Torture to define and measure social functioning domains among torture survivors living in the United States. The instrument was developed through scientific test construction methods and normed among torture survivors receiving services at CVT.\n\nInteroceptive awareness will be assessed using the Multidimensional Assessment of Interoceptive Awareness (MAIA), a thirty two item instrument rated on a five point scale.\n\nCardiovascular health will be assessed using three indicators: blood pressure (BP), heart rate (HR), and heart rate variability (HRV).\n\nDATA ANALYSIS PLAN presented below specific to aim.\n\nAim 1. Implementation Science Aim. Explore uptake of TCI Massage within CVT by examining key implementation science outcomes of acceptability and appropriateness among refugees and asylum seekers from diverse cultural backgrounds.\n\nAnalytic Method. Descriptive statistics derived from CVT electronic health records will describe trends in demographics and health characteristics among study participants as well as the number of patients referred, enrolled, and massage sessions attended. For analysis of in depth interviews and focus groups, a combination of a priori and inductive coding will be applied. A priori codes will address dimensions of acceptability and appropriateness with particular attention to trauma, cultural considerations, and language capacity. An emergent and iterative coding approach will also identify unanticipated themes and support increasingly granular analyses. Interview data, focus group data, and electronic health record data will be triangulated to assess the acceptability and appropriateness of the intervention.\n\nAim 2. Implementation Science Aim. Examine the integration of TCI Massage into the current psychosocial care model used at CVT.\n\nAnalytic Method. Descriptive statistics on feasibility and fidelity will identify trends and patterns in ongoing intervention implementation. Descriptive statistics will specify the number of participants referred, enrolled, and massage sessions received. A cost analysis framework will describe the overall costs of providing massage therapy within the clinic including salaries, local between clinic travel, equipment, and supplies. These costs will inform the overall assessment of implementation success and considerations for sustainability.\n\nAim 3. Health Outcome Aim. Examine the effectiveness of TCI Massage for torture and war trauma survivors to reduce distress including mental health symptoms, pain, and heart rate variability and improve coping including interoceptive awareness and social functioning.\n\nAnalytic Method.\n\nPreliminary analyses. Standard statistical tests will assess key analytic assumptions. Baseline equivalence between treatment and control groups will be examined on demographic characteristics such as age and cultural background and baseline clinical characteristics such as PTSD symptoms and chronic pain levels using t tests and chi square tests. Variables demonstrating baseline imbalance will be included as covariates in subsequent analyses.\n\nMain analysis. Treatment effects will be assessed using multilevel modeling approaches. Analyses will follow an intent to treat framework.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Refugee or asylum seeker who has experienced torture or war related trauma\n* Receiving care at one of the CVT clinics offering the study\n* Moderate to high levels of pain as assessed through the Graded Chronic Pain Scale (Grade I or higher)\n* Age between 18 and 70 years\n\nExclusion Criteria:\n\n* Currently receiving massage therapy services\n* Presence of high risk medical condition(s) requiring referral to more intensive services or hospitalization such as inpatient psychiatric care'}, 'identificationModule': {'nctId': 'NCT07482358', 'acronym': 'TCI-MT', 'briefTitle': 'TCI-Massage Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'The Center for Victims of Torture, United States'}, 'officialTitle': 'Trauma-Informed and Culturally-Responsive Integrated Massage Therapy (TCI-Massage): An Implementation and Effectiveness Study', 'orgStudyIdInfo': {'id': 'TCI-Massage'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TG', 'interventionNames': ['Other: TCI-Massage']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CAU', 'interventionNames': ['Other: TCI-Massage']}], 'interventions': [{'name': 'TCI-Massage', 'type': 'OTHER', 'description': 'Intervention Condition: Trauma-informed and Culturally-responsive Integrated model of massage therapy (TCI-Massage). Massage therapy, over clothes, is provided for one hour once a week for eight weeks.', 'armGroupLabels': ['CAU', 'TG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80121', 'city': 'Centennial', 'state': 'Colorado', 'country': 'United States', 'facility': 'CVT', 'geoPoint': {'lat': 39.57916, 'lon': -104.87692}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Center for Victims of Torture, United States', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Minnesota', 'class': 'OTHER'}, {'name': 'University of Washington', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}